NCT01208961: ECLIPSE

A Randomized, Open-label, Four-Way Crossover Study to Compare the Relative Bioavailability of a Single Dose of Epanova® With Lovaza® After a Low-Fat and High-Fat Meal

Completed Phase 2 Results posted Last updated 19 June 2015

What this trial tests

Phase 2 trial testing Epanova (4 g) and Lovaza (4 g) in Severe Hypertriglyceridemia in 54 participants. Completed in 1 November 2010.

Timeline

1 September 2010

Primary endpoint
1 November 2010

1 November 2010

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	54
Start date	1 September 2010
Primary completion	1 November 2010
Estimated completion	1 November 2010
Sites	1 location across United States

Drugs / interventions tested

• Epanova (4 g) and Lovaza (4 g) — full drug profile →
• Lovaza (4 g) and Epanova (4 g) — full drug profile →

Conditions studied

• Severe Hypertriglyceridemia — all drugs for Severe Hypertriglyceridemia →

Sponsor

AstraZeneca — full company profile →

Who can join

18 and older, any sex, with Severe Hypertriglyceridemia. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• AUC(0-t): Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (the Final Time With a Concentration ≥ LOQ)
  Time frame: Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.
  Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.
• AUC(Inf): Area Under the Plasma Concentration-time Curve From 0 to Infinity
  Time frame: Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.
  Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.
• C(Max): Maximum Plasma Concentration
  Time frame: Blood samples were obtained pre-dose at -1.0, -0.5, and 0 hours and after dose administration at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12 and 24 hours.
  Analyses of the outcome measures presented are for baseline-adjusted data for total (esterified and unesterfied) EPA and DHA since the presence of endogenous levels of these fatty acids would likely contribute to intra-subject variability and affect the analyses and interpretation.

Sponsor's own description

The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.